Vivli held a webinar to discuss recent developments in data privacy laws and their impact on data sharing.
The webinar was held on Monday, April 24th at 3pm CEST / 2pm BST / 9am EDT.
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The People’s Republic of China (PRC) enacted a comprehensive data privacy law called the Personal Information Protection Law (PIPL) in November 2021. This law adds to an already complex data privacy framework in the PRC, which also includes the Regulation of Human Genetic Resources, the Biosecurity Law of the PRC and the Data Security Law of the PRC. This webinar will focus on key implications of the PIPL and these other PRC laws for the sharing of clinical trials data generated in the PRC for further research purposes. The speakers will also make comparisons between PIPL and the European Union’s General Data Protection Regulation (“GDPR”), another global privacy law that has had a significant impact on the sharing of clinical trial data.
Learning objectives for this session include:
• Understand the basics of PIPL
• Understand how PIPL affects sharing of clinical trials data across international borders
• Understand key differences between PIPL and GDPR
• Rebecca Li, Vivli
• David Peloquin, Ropes & Gray
• Katherine Wang, Ropes & Gray
This webinar is intended for organizations and individuals that share data and will be particularly useful for those who focus on data privacy.
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Rebecca Li will be speaking at the NIA-DUKE-Alzheimer’s Association Workshop held on March 15-16th sponsored by the National Institute on Aging.
The focus of the talk by Rebecca Li and Katherine Welsh-Bohmer (Duke University School of Medicine) is on how the Vivli platform can be used to access trials in Alzheimer’s Disease. Dr. Welsh-Bohmer will discuss the TOMMORROW trial – a large prevention study in Alzheimer’s Disease – as a specific use case.
The NIH Data Management and Sharing (DMS) policy went into effect in January 2023 to promote the sharing of scientific data.
Please watch Vivli’s recent webinar and find out more about how Vivli can help you navigate the NIH Data Management and Sharing policy. Hear from academic staff on their experiences in supporting researchers with their Data Management and Sharing Plans (DMSP).
During this webinar, we:
- Provide an overview of Vivli, including what types of data should be shared in Vivli
- Discuss the benefits of using Vivli to meet the data sharing requirements of your NIH grant
- Review the steps to completing the NIH DMSP and budget justification
- Hear views from academic staff on their experiences supporting researchers to complete the new NIH DMSP
- Anne Seymour, Johns Hopkins University
- Amy Nurnberger, Massachusetts Institute of Technology
- John Borghi, Stanford University
- Rebecca Li and Julie Wood, Vivli
Participants had the opportunity to ask questions. This webinar is most useful for current or prospective NIH grantees or those who support them.
Version 3.0 of the Vivli platform has been released and is available to users. The key change with the new version of the platform is that it is now possible for researchers to submit their completed clinical study through platform. This change is aimed academic researchers so they can meet funder requirements.
“To make it easier for researchers who want to share the results of their completed clinical trials to meet funder and publication requirements, it is now possible for researchers to answer a few questions and submit their studies for sharing,” said Julie Wood, Vivli Senior Director. “We think this will make it much easier for academic researchers to share their data.”
Other minor useability changes have been made and the tools and software in the research environment has been updated.
“We are delighted to welcome Galapagos as a member of Vivli and to be able to partner with them to manage requests received for their individual patient-level data from completed clinical trials,” said Rebecca Li, Vivli Executive Director.
The Galapagos mission is to develop transformational medicines in areas of high unmet need by combining internal with external science with the goal to add years of life and improve quality of life of patients across the globe.
At Galapagos, we believe that transparency of clinical study data promotes strong scientific research and advances science and medicine. Galapagos commits to ensure full compliance with all applicable laws and regulatory guidance and provides specific attention to the protection of personal data at study participant level.
For more information about the conditions for accessing Galapagos data, please visit their member page. For additional information about Membership in Vivli, learn more here.
We are delighted to share with you Vivli’s 2022 Progress Report, which highlights our milestones to date and plans for the year ahead.
We look forward to continuing to grow together in 2023 and beyond, as leaders in data sharing and transparency, working together towards our end goal of advancing human health.
Vivli’s Executive Director, Rebecca Li, will speak at the AI-Enhanced Clinical Trials Summit in Boston on December 8th for “Unlocking Sensitive Healthcare Data To Optimize Clinical Trials And Encouraging Clinical Research Data Sharing.” Highlights will include the ethical and practical challenges of accessing patient data and how best to overcome shared challenges.
With drug development costs rapidly increasing, decision makers are right to be turning to novel AI/ML technologies to optimize clinical trial processes and de-risk drug development pipelines. Looking from both a patient-engagement and internal-process perspective, the AI-Enhanced Clinical Trials Summit takes a closer look at how available and scalable AI technologies are accelerating and improving clinical trials.
Learn more here.
Vivli hosted a webinar to discuss applications of the SAFE Data Standard as defined in “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data.”
The webinar was held on November 29th, 4pm CET/10am EST/7am PST.
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This one-hour webinar features authors of the recently published paper “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data,” presenting how data transformation is measured as part of the SAFE Data Standard and how to apply the SAFE Data Standard in different security contexts. This webinar is intended to help sponsors understand how to use the SAFE Data Standard to securely share rich clinical trial data to preserve data utility and for users of data to understand how accessing data in different contexts may change the utility of the data being provided.
Read the paper here!
Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
Aaron Mann, CEO, Clinical Research Data Sharing Alliance
Marcia Levenstein, Senior Advisor, Vivli
“Enabling the Data Sharing Ecosystem”
Vivli’s 2022 Annual Meeting was held on Wednesday, November 2nd, 2022, 9:00am – 12:00pm EST / 2:00 – 5:00pm CET / 10:00pm – 1:00am JST. This meeting served as a chance to allow Vivli data contributors, key collaborators and funders to discuss data sharing and its importance for furthering scientific discoveries.
Vivli Update for 2022, Rebecca Li, Executive Director, Vivli
Sharing COVID-19 Clinical Trial Data on Vivli
Reflecting on best practices and current experience
- Julie Holtzople, Senior Director Clinical Transparency and Data Sharing, AstraZeneca
- Steve Kern, Interim CEO, Global Health Labs
- Ben Rotz, Associate Vice President – Global Medical Policy Strategy and Operations, Lilly
- David Leventhal, Enterprise Clinical Trial Data Sharing Lead, Pfizer
- Rebecca Sudlow, Global Lead Patient Level Data Sharing, Roche
NIH Data Sharing Policy Changes in 2023
- Dr. Susan Gregurick, Associate Director for Data Science and Director of the Office of Data Science Strategy (ODSS), NIH
Spotlighting data challenges Vivli is embarking on with key partners in 2022-2023
- Deniz Dalton, Program Officer, The Leona M. and Harry B. Helmsley Charitable Trust, presenting “Moving Type 1 Diabetes and Exercise Data to Solutions”
- Tetsuyuki Maruyama, Executive Director, Alzheimer’s Disease Data Initiative (ADDI), presenting “ADDI/Vivli Data Challenge in Alzheimer’s Disease”
Next Steps and Discussion
Vivli’s Program Manager, Catherine D’Arcy, spoke at DIA Global Clinical Trial Disclosure & Transparency Conference on October 18th in Amsterdam, presenting “Clinical Research Data Use: Insights From Vivli’s Experience Of Data Sharing.” More than 140 delegates attended from 16 countries.
The 2022 Global Clinical Trial Disclosure and Data Transparency Conference builds on prior successful conferences to leverage learnings from regulators and international experts in the field. This event will provide essential, timely information about global clinical trial disclosure, data transparency, data sharing for secondary research, and the EU Clinical Trial Information System (CTIS) with the focus on transparency in relation to the protection of personal data and commercially confidential information. It brings leading study sponsors from industry and academia together with regulators and other players to exchange knowledge and share their experiences with the implementation of Clinical Trial Disclosure and Data Transparency from various viewpoints.